Kornimate/medical-research-clean huggingface dataset:
uci 03-72 prostate cancer detection by serum proteomic profiling

Conditions: Prostate Cancer

Summary: : researchers would like to see if a new test called seldi (surface enhanced laser desorption ionization) analysis can predict biopsy results better than psa tests.

a blood sample of approximately 30 cc will be collected prior to the patients standard of care radical prostatectomy surgery. this blood will be used for the seldi analysis. the remainder of the blood sample will be stored and may be used for the psa test at a later date. the patient will have a final blood draw 3 months to 1 year following surgery.

Eligibility criteria:
inclusion criteria: * for all subjects: * men 50 years of age or older. * serum psa greater than or equal to 2.5 ng/ml and less then or equal to 10.0 ng/ml determined by a measurement within the past six months, and/or digital rectal exam suspicious for prostate cancer as determined by the patient's urologist. * it has been determined by the treating physician that a prostate biopsy is clinically indicated. * patients will have already been diagnosed with prostate cancer and scheduled for a radical prostatectomy. for study on treatment effect * men with clinically localized prostate cancer (total psa \< 20 ng/ml and clinical t2b or less). * men with organ confined prostate cancer as determined by final pathologic diagnosis. exclusion criteria: * exclusion criteria for all subjects: * known prostate cancer or prior treatment for prostate cancer. * acute prostatitis. * untreated urinary tract infection. * presence of foley catheter or any urethral instrumentation in the previous 48 hours. * hormonal therapies including lhrh agonists, oral anti-androgens, estrogenic compounds, proscar or any phytotherapies within the previous 6 months. exclusion criteria (for study on treatment effect) * men with non-organ confined prostate cancer. * men with detectable serum psa levels more than 1 months following radical prostatectomy.

Keywords: prostate cancer detection by serum proteomic profiling
care ecosystem: navigating patients and families through stages of care

Conditions: Dementia; Alzheimer Disease; Dementia, Vascular; Lewy Body Disease; Frontotemporal Lobar Degeneration; Memory Disorders

Summary: this is a randomized clinical trial evaluating the benefits of a program that supports model care for persons with dementia and their family caregivers. subjects were recruited from california, nebraska and iowa. subjects determined to be eligible were consented and randomized into one of two groups. two thirds of patients were enrolled into navigated care that provided them with assistance in meeting important benchmarks in their care, for example completion of legal and financial planning and strategies for minimizing caregiver burden. one third of patients were enrolled to a control group, entitled survey of care. outcomes include quality of life, health care utilization, caregiver burden, satisfaction with care, caregiver depression, and caregiver self-efficacy.


Eligibility criteria:
this study will enroll patients as well as their primary caregivers as research participants. inclusion criteria for patient participants: 1. patient has a diagnosis of dementia with a progressive course 2. patient has a primary caregiver (identified as having primary responsibility for patient) that is eligible for and agrees to join the study 3. patient is covered by medicare or medi-caid or is medi-pending 4. patient is expected to live at least 3 months based on assessment by the referring provider, the patient's primary care provider, or medical record review 5. patient speaks either english, cantonese, mandarin, or spanish 6. patient lives in california or nebraska or iowa 7. patient is age 45 or older inclusion criteria for caregiver participants: 1. caregiver has primary responsibility for dementia patient that is eligible for and agrees to join the study 2. caregiver speaks either english, cantonese, mandarin, or spanish 3. caregiver is a legal adult exclusion criteria: 1. patient resides in a nursing home or skilled nursing facility at time of enrollment 2. participant is enrolled in a similar clinical trial that precludes their participation in our trial 3. patient is pregnant

Keywords: pragmatic clinical trial family caregivers patient care management
does use of rapid response eeg impact clinical decision making

Conditions: Nonconvulsive Status Epilepticus; Seizures

Summary: this study is designed as a prospective, non-randomized, observational, multicenter clinical trial. the primary aim of this study is to observe if the use of the rapid responds electroencephalography (eeg) system impacts physician decision making. secondary aims include exploring the safety and performance information of the ceribell eeg system compared to conventional eeg system. the study will recruit physicians (faculty physicians and trainees) at up to five institutions and examine the impact of rapid response eeg when providing care to patients in whom eeg recording has been ordered for clinical reasons.


Eligibility criteria:
inclusion criteria: * patients undergoing clinically ordered eegs. exclusion criteria: * none
nasm opt for gluteal enhancement in non-athletic women: an rct

Conditions: Low Back Pain; Muscle Weakness; Body Image Disturbance

Summary: this rct evaluates a 12-week nasm opt program targeting gluteal muscle strength, hip aesthetics (shape, lift, circumference), and low back pain in 120 non-athletic women. the intervention group performed structured resistance training, while the control group engaged in general exercise. outcomes included gluteal strength (dynamometer), aesthetic satisfaction (likert scale), and functional performance (squat test).

participants were randomized to nasm opt (3 weekly sessions: stabilization, strength, and hypertrophy phases) or general exercise (brisk walking/aerobics). measurements at baseline and 12 weeks included gluteal strength, hip circumference, low back pain (vas), and perceived aesthetics.

Eligibility criteria:
inclusion criteria: * non-athletic women (no exercise in prior 6 months). * interest in improving hip aesthetics. * no musculoskeletal injuries. exclusion criteria: * pregnancy * chronic illness * exercise contraindications

Keywords: nasm opt gluteal muscles hip aesthetics non-athletic women resistance training
sensory processing difficulties in adults and adolescents

Conditions: Sensory Processing Dysfunction

Summary: the purpose of this study is to establish normative data for the adult/adolescent sensory history (ash) and to determine if the ash is able to discriminate between individuals aged 13-95 years, with autism spectrum disorder (asd) with or without co-morbid sensory processing disorder (spd), individuals with spd with no co-morbid asd, and individuals who are typically functioning. it is anticipated that individuals with asd will have the most problems with sensory processing, those with spd will also have problems in comparison to typical individuals. it is also hypothesized that the measure will be able to discriminate between the three groups.


Eligibility criteria:
inclusion criteria: * autism and sensory processing groups aged 18-95 years, typical group aged 13-95 years * have no self-reported diagnosed neurological motor coordination problem (e.g. cerebral palsy) * have no mental health diagnoses involving psychosis (e.g. manic-depression or schizophrenia) * be able to read and speak sufficient english as survey is only available in english. exclusion criteria: * outside of the designated age range * unable to complete the survey independently

Keywords: sensory processing autism
bluesync field evaluation

Conditions: Bradycardia

Summary: the purpose of this field evaluation is to collect and evaluate information related to carelink transmission compliance as well as patient perceived benefit of bluesync™ and the health care provider perception of the value of bluesync™ and satisfaction with bluesync™.

the primary goal is to learn how many carelink quarterly scheduled transmissions are completed within a prescribed time period to assess carelink scheduled transmission compliance. the evaluation will also assess adoption to remote monitoring, patient perceived benefit of bluesync™ (how patients interact with the smart device application) and health care provider perception of the value of bluesync™ and satisfaction with bluesync™ (benefits experienced by clinicians that use bluesync™). this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 crf 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 crf 11.24 and 11.44).

Eligibility criteria:
inclusion criteria: * patient will be/has been implanted with an azure™ or percepta™, serena™, solara™ crt-p device compatible with bluesync™ (both new and replacement devices are allowed) * patient must own a smart device (smartphone or tablet) that meets system requirements and be willing to use during evaluation period * patient must be able to complete the required 12-month follow-up after enrollment * patients must be of legal age according to local law exclusion criteria: * patient unwilling to complete required surveys during 12-month evaluation period

Keywords: remote monitoring transmission compliance patient engagement
resection of colorectal liver metastases with or without routine hilar lymphadenectomy

Conditions: Hepatic Metastases; Colorectal Cancer

Summary: it is uncertain, whether hilar lymphadenectomy should be performed routinely in patients undergoing resection of colorectal liver metastases. for this reason it is the aim of the present prospective randomized trial to evaluate, if routine lymphadenectomy reduces recurrent disease in patients undergoing resection of colorectal liver metastases.

routine lymphadenectomy in patients undergoing hepatic resection for colorectal liver metastases may improve outcome of further patients due to the presence of micrometastases that have been shown to be of prognostic relevance. while previous studies highlight the clinical significance of perihepatic lymph node metastases, the outcome of patients with and without hilar lymphadenectomy has not yet been compared and thus no clear conclusion about the clinical value of routine hilar lymphadenectomy in crc patients undergoing resection of liver metastases can be drawn from present data. as disease recurrence occurs frequently and may affect up to 75 % of patients, further strategies are required to improve postoperative outcome. routine hilar lymphadenectomy may offer an effective approach to remove residual disease and by this to reduce disease recurrence with little additional morbidity. for this reason it is the aim of the present prospective randomized trial to evaluate, if routine lymphadenectomy reduces recurrent disease in patients undergoing resection of colorectal liver metastases.

Eligibility criteria:
inclusion criteria: * patients scheduled for curative (r0) resection * no evidence of extrahepatic disease * no history of previous hepatic lymphadenectomy * age equal or greater than 18 years * written informed consent exclusion criteria: * expected lack of compliance * impaired mental state or language problems * history of another primary cancer, except: * curatively treated in situ cervical cancer or curatively resected non-melanoma skin cancer * other primary solid tumour curatively treated with no known active disease present and no treatment administered for ≥ 5 years prior to randomisation

Keywords: resectable hepatic metastases of colorectal cancer
pv loop and pulmonary hypertension

Conditions: Pulmonary Vascular Resistance Abnormality

Summary: the right ventricular (rv) systolic function is a key determinant of outcome in patients with pulmonary hypertension and elevated pulmonary vascular resistance. as the pulmonary artery pressure and vascular resistance increase (i.e. rv afterload) in these patients, so does the right ventricular contractility in an attempt to maintain cardiac output. this is response of a ventricle to its afterload is termed ventriculo-arterial (va) coupling. however, there is a limit to this increase in contractility after which va uncoupling occurs ultimately leading to decrease cardiac output and right ventricular failure. the accepted gold standard for measurement of va coupling is the ratio of the end systolic ventricular elastance (ees) to the end systolic arterial elastance (ea) measured invasively via high fidelity conductance catheters during cardiac catheterization. in this study, the aim is to devise a non-invasive scoring system that can identify va uncoupling in patients with elevated pulmonary vascular resistance using echocardiography, cardiac mri, cardiopulmonary exercise testing and brain natriuretic peptide levels. the hypothesis is that a group of morphologic and functional variables obtained noninvasively can differentiate an rv with va coupling from that with va uncoupling.


Eligibility criteria:
inclusion criteria: * children 1-21 years of age * patients referred for cardiac catheterization for hemodynamic evaluation due to concern for pulmonary hypertension * structurally normal heart exclusion criteria: * pulmonary hypertension secondary to pulmonary venous hypertension defined as pulmonary capillary wedge pressure of more than or equal to 15mmhg * pulmonary hypertension secondary to mixed pulmonary arterial and venous hypertension * patient will be excluded from performing an mri if they have: claustrophobia, metal implants or allergy to contrast * patients will be excluded from performing a cardiopulmonary exercise test (cpet) if they are: 1) less than 8 years or 2) unable to follow instructions to run on a treadmill.

Keywords: pulmonary vascular resistance pediatric va uncoupling
evaluate the safety and effectiveness of sovaldi in participants with chronic hepatitis c virus (hcv) infection in korea

Conditions: Hepatitis C Virus

Summary: the objectives of this study are to collect and assess data related to safety and effectiveness of sovaldi treatment regimens, per the approved prescribing information for sovaldi, in routine clinical practice and report results to korean ministry of food and drug safety (mfds).


Eligibility criteria:
key inclusion criteria: * individuals aged 12 years and older who are living in korea * individuals with chronic hcv infection eligible for treatment with sovaldi as indicated in the approved prescribing information for sovaldi * individuals who have been informed of all pertinent aspects of the study and have voluntarily signed personal information protection act (pipa) consent form; pediatric individuals who have their legally authorized representatives sign the pipa consent form key exclusion criteria: * individuals treated with sovaldi outside of the approved prescribing information for sovaldi in korea * individuals who have a contra-indication (refer to the korea prescribing information) * individuals who have a contra-indication to ribavirin or peginterferon alfa or daclatasvir * pregnant or breast feeding women * individuals who have previously been administered sovaldi * individuals participating in a concurrent hcv clinical trial * individuals planning on leaving the country during the study period note: other protocol defined inclusion/exclusion criteria may apply.
digital variance angiography in diagnostic angiographies for effective radiation dose reduction

Conditions: Peripheral Arterial Disease; Peripheral Artery Disease; Femoral Artery Stenosis; Femoral Artery Occlusion; Popliteal Stenosis; Iliac Artery Stenosis; Crural Artery Thrombosis; Limb Ischemia

Summary: digital variance angiography (dva) is a new tool in medical imaging with proven image quality reserve. the previously observed quality reserve of digital variance angiography (dva) in lower extremity angiographies, allowed to lower radiation exposure by 70 % during dsa in lower extremity diagnostic angiographies with non-inferior image quality. the aim of this study is to apply this non-inferior image quality and use it for radiation exposure reduction in diagnostic lower limb angiography. the project would prospectively block-randomise (50:50) patients, who undergo elective diagnostic angiography into two groups: a comparator group examined by means of conventional dsa using a standard care protocol (siemens artis zee, extremities care setting, 1.2 µgy/frame) (group b) and a study group examined by means of dva using a low-dose protocol (0.36 µgy/frame corresponding to 70% decrease of radiation dose) (group a). during each procedure the investigators record radiation exposure (cumulative dosage, dose area product) and contrast media usage and procedural time then compare the results of the groups. qualitative image review is done to compare conventional dsa and reduced radiation exposure dva images after image acquisition. our hypothesis is that with the previously proven non-inferior image quality, the investigators will be able to reduce radiation exposure of the participants and also staff members in everyday clinical practice.


Eligibility criteria:
inclusion criteria: * patients with lower limb peripheral arterial disease, admitted for diagnostic angiography * fontaine ii- iv * normal renal function: gfr\> 60ml/min/m2 * age \> 18 exclusion criteria: * acute myocardial infarction * severe heart/liver/renal failure * iodine contrast allergy * atrioventricular block * coagulopathy and hematological bleeding disorders

Keywords: radiation protection x-ray angiography digital variance angiography digital subtraction angiography peripheral arterial disease kinepict image acquistion image quality radiation exposure
establishing a pediatric reference range for the 13c-spirulina gastric emptying breath test (gebt)

Conditions: Gastroparesis

Summary: the goal of this clinical trial is to define the normal response to the 13c-spirulina gastric emptying breath test (gebt) in children, so that we can use this test to help diagnose children that are suspected of having a condition called gastroparesis, which means that food doesn't empty from their stomach normally. participants will blow into test tubes to collect breath samples before and after eating a scrambled egg gebt meal that contains a small amount of specially grown spirulina (a blue-green alga used as a dietary supplement) that contains mostly carbon-13 (a non-radioactive kind of carbon atom). analysis of the amount of 13c in the carbon dioxide in breath before and after eating the gebt meal can measure how fast food is emptying from the stomach.

children will complete questionnaires to ensure that they are qualified to enter the study and are likely to have normal gastric emptying rates. informed consent/assent will be obtained. breath samples will be collected by children blowing into test tubes before and after eating a 13c-spirulina gebt meal. breath samples will be collected and the test will be administered via telehealth or at one of the children's hospital clinics. researchers will analyze results from different age groups to see if there are differences in normal gastric emptying in younger/older children and boys/girls.

Eligibility criteria:
inclusion criteria: * children ages 7 to 18 years who provide written assent and whose parents provide written consent for participation * healthy and without any significant prior medical history or developmental delays * able to eat the test meal and provide breath samples.- exclusion criteria: any known physician-diagnosed medical (gastrointestinal, pancreatic, or liver disease that may cause malabsorption, neurological) or psychiatric disease * chronic pulmonary disease including moderate/severe reactive airway disease requiring treatment with a daily inhaler * type 1 or 2 diabetes * chronic gastrointestinal symptoms or functional gastrointestinal disorders * mental retardation or pervasive developmental disorder * currently receiving prescription drug therapy that may affect gastric motor function or sensation * any over-the-counter or herbal supplements that may affect gastric motor function or sensation * allergy to spirulina, egg, milk, wheat or gluten (unless consuming gluten free crackers with the test meal) or known intolerance to any ingredient in the test meal
investigation of the effects of physiotherapy in patients with platelet rich plasma (prp) applied knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: this study evaluates effects of prp and physiotherapy on pain, physical function and quality of life in patients with knee osteoarthritis.

prp has been reported to have a low to moderate level of evidence in patients with knee osteoarthritis (oa) in reducing pain and improving function. similarly, in individuals with knee osteoarthritis, exercise has been reported to be effective in reducing the pain and improving physical function of the knee oa patient in the short term, and may be even more effective with individual exercise programs. however, there is no study examining the effect of prp and exercise together. prp and exercise can be more effective together. the aim of our study was to investigate the effects of physiotherapy on pain, physical function and quality of life in patients with knee oa who underwent prp injection.

Eligibility criteria:
inclusion criteria: * grade 2-3 according to kellgren lawrence osteoarthritis classification, * patients with knee osteoarthritis who underwent prp injection at least three days ago, * being volunteer exclusion criteria: * any intra-articular application and / or physiotherapy and rehabilitation in the last 6 months, * have any other orthopedic problems involving the lower extremities * having cognitive problems, * having additional neurological, rheumatologic and / or oncological problems

Keywords: knee osteoarthritis platelet rich plasma exercise